Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.51 µg/L
Assessment factor:
1 000

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.051 µg/L
Assessment factor:
10 000

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
100

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
3.97 mg/kg sediment dw
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.4 mg/kg sediment dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
2.13 mg/kg soil dw
Assessment factor:
10
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Short-term toxicity tests for algae, Daphnia and fish are available for the substance. The EC50 value for Daphnia is 0.51 mg/l, whereas the LC50 for fish is 1.5 mg/L and the ErC50 for algae is > 0.66 mg/L. Based on the lowest available acute data for Daphnia with an EC50 value of 0.51 mg/L the substance needs to be classified as Aquatic Acute 1 (H400, Table 4.1.0; a).

As only one chronic value is available (algae), the aquatic chronic classification needs to be derived on both chronic and acute toxicity data and the most stringent outcome needs to be taken into consideration. The only chronic available value is the ErC10 of algae being 0.37 mg/L which would indicate a Chronic 2 classification because the substance is not readily biodegradable. The lowest acute toxicity value of the other species is in the range of 0.1 -1 mg/l (Daphnia) and the substance is not readily biodegradable (despite BCF is < 500 (<27)) based on which the substance shall be classified as Chronic 1 (Table 4.1.0 b, iii). Therefore, based on short-term toxicity data, the substance needs to be classified as Category Chronic 1 (H410), according to EU CLP (EC no 1272/2008 and its updates).

Overall, it can be concluded that Pinyl Isobutyraldehyde needs to be classified as Aquatic Acute 1 and Aquatic Chronic 1 (H400, H410) according to EU CLP (EC 1272/2008 and its amendments).